JP7228496B2 - Intubation Lubricant - Google Patents

Description

TECHNICAL FIELD The present invention relates to a lubricant having appropriate fluidity and wettability that can be applied to the inside of an intubation tool or to an endoscope so as to facilitate smooth insertion and not obstruct the field of view of the endoscope.

In surgical operations such as pulmonary resection, thoracic esophageal cancer, or descending thoracic aortic aneurysm, separate lung ventilation is performed so that the left and right lungs can be ventilated independently or one lung can be ventilated. At this time, a special intubation device called a double lumen tube is used, and after inserting the tube into a predetermined position, a balloon called a cuff placed at the tip of the tube is inflated to fix the tube. At this time, the bronchial videoscope insertion part is inserted into the intubation tool to confirm that it is placed in an appropriate position, and it is placed while checking the tracheal bifurcation. Also, during cardiopulmonary resuscitation, long-term artificial respiration management, or general anesthesia, a tracheal tube is directly inserted into the trachea and left in place to secure the airway. After intubation into the trachea, a bronchial videoscope insertion section is inserted into the tracheal tube to observe the inside of the trachea. In addition, there are cases where an endoscope such as a videoscope is directly inserted into body cavities or tissues such as the gastrointestinal tract, urethra, large and small intestines, as well as the trachea. Possible insertability and lubricity are required.

When inserting such a videoscope, it may become difficult to insert due to friction with the tracheal tube or the like. For this reason, attempts have been made to improve the lubricity by coating the inside of the tracheal tube and the surface of the insertion part of the bronchial videoscope with silicone oil, olive oil, glycerin, jelly containing lidocaine, liquid anesthetic, polyethylene glycol, etc. is done.

However, although surface coating with oil, glycerin or the like lowers the coefficient of dynamic friction, there is a drawback in that the oil or glycerin is washed away and the lubricating effect does not last long (see Patent Document 1).

A balloon called a cuff is attached to the tracheal tube to prevent leaks between the tracheal wall and the tube and to prevent displacement of the tracheal tube, and the cuff is often made of polyvinyl chloride or polyurethane. If liquid anesthetic containing lidocaine adheres to a cuff made of polyvinyl chloride, it may break in a short period of time and cause pinholes. It is also not preferred for clinical use.

In order to overcome these drawbacks, the applicant of the present invention has made intensive studies on a lubricant in which the blending amount of a thickener is adjusted in order to improve the durability of lubricity. It was found that the higher the viscosity, the longer the lubricating effect lasts, but if the viscosity is too high, it adheres to the lens of the videoscope, obstructing the field of view and causing image distortion. Found a problem.

JP-A-11-244375

The present invention has been made in view of the newly discovered problems as described above, and can be applied to the inside of an intubation tool or an endoscope such as a videoscope to smoothen their insertion. To provide a lubricant having suitable fluidity and wettability without obstructing the visual field of an endoscope.

The present inventors have found that the above problems can be effectively solved by blending components (A) to (C) described below in specific proportions, and have completed the present invention.

That is, the present invention is as follows.
[1] Characterized by containing 0.3 to 2% by mass of the following component (A), 0.1 to 2% by mass of the component (B), and 1 to 30% by mass of the component (C), Lubricant for intubation equipment.
(A) pullulan (B) water-soluble thickener other than component (A) (C) polyhydric alcohol having 3 to 6 carbon atoms [2] component (B) is xanthan gum or carboxyvinyl polymer [1] Lubricant for intubation tools according to.

INDUSTRIAL APPLICABILITY According to the present invention, there is provided a lubricant for an intubation tool that can smoothly insert an endoscope into an intubation tool, and does not interfere with the visual field of the endoscope because the fluid is less likely to pool. be done.

The "lubricant for an intubation tool" in the present invention refers to a mode in which a lubricant is applied to the intubation tool side (e.g., bronchial tube) when endoscopy is performed at a medical site, or to the endoscope side (e.g., , a video scope) can be used in one or both of the embodiments in which a lubricant is applied, and both embodiments are included in the scope of the present invention.

The intubation tool lubricant of the present invention contains components (A) to (C). Each component will be described below.
[Component (A)]
Component (A) is pullulan, a naturally occurring polysaccharide (sugar polymer ). The three glucose units that make up maltotriose are linked by α-1,4 glycosidic bonds, and maltotriose is linked to each other by α-1,6 glycosidic bonds.
Although the molecular weight of component A is not particularly limited, it is preferably 100,000 to 300,000.
Commercially available products of component A include those manufactured by Hayashibara Co., Ltd. under the trade name of "Cosmetic Pullulan".

The content of component (A) in the intubation tool lubricant is 0.3 to 2% by mass, preferably 0.5 to 1.2% by mass. If the content is less than 0.3% by mass, the coefficient of dynamic friction becomes large and the elongation is insufficient. On the other hand, if the content is more than 2% by mass, the field of view of the video scope and the prevention of liquid pooling become insufficient.

[Component (B)]
Component (B) is at least one selected from water-soluble thickeners other than component (A).
Examples of the water-soluble thickener include natural polysaccharides such as carrageenan, xanthan gum, dextrin, methylcellulose, hyaluronic acid and chitosan; semi-synthetic polysaccharides such as ethylcellulose, hydroxyethylcellulose and hydroxypropylcellulose; polyvinyl alcohol and polyacrylic acid. , polymethacrylic acid, carboxyvinyl polymer, and synthetic polymers such as acrylic acid/alkyl acrylate (having 10 to 30 carbon atoms) copolymers. Among these, xanthan gum, hydroxypropyl methylcellulose, carboxyvinyl polymer, acrylic acid/alkyl acrylate (C10-30) copolymer are preferred, xanthan gum and carboxyvinyl polymer are more preferred, and xanthan gum is most preferred.
Two or more of the water-soluble thickeners described above can be appropriately combined and used as the component (B) of the lubricant for an intubation tool of the present invention.

The content of component (B), which is a water-soluble thickener in the lubricant for intubation devices, is 0.1 to 2% by mass, preferably 0.2 to 1.5% by mass. If the content is less than 0.1% by mass, the coefficient of dynamic friction becomes large and the liquid pooling prevention property is insufficient. On the other hand, if the content is more than 2% by mass, the field of view of the video scope and the prevention of liquid pooling become insufficient.

[Component (C)]
Component (C) is a polyhydric alcohol having 3 to 6 carbon atoms, such as glycerin, pentylene glycol, 1,3-butylene glycol, erythritol, propylene glycol, dipropylene glycol, diglycerin, hexylene glycol, isoprene. Examples include polyhydric alcohols such as glycol. Among these, glycerin, propylene glycol and diglycerin are preferred, and glycerin and propylene glycol are more preferred.
The above polyhydric alcohols having 3 to 6 carbon atoms can be appropriately used in combination of two or more as the component (C) of the lubricant for an intubation tool of the present invention.

The content of the polyhydric alcohol having 3 to 6 carbon atoms, which is the component (C) of the lubricant for intubation devices, is 1 to 30% by mass, preferably 3 to 10% by mass, more preferably 5 to 8% by mass. . If the content is less than 1% by mass, the coefficient of dynamic friction becomes large. On the other hand, if the content is more than 30% by mass, the field of view of the video scope and the prevention of liquid pooling become insufficient.

The intubation tool lubricant of the present invention contains water in addition to the above components (A) to (C). The content of water is not particularly limited as long as it is the balance of components (A) to (C), but it preferably contains 70 to 95% by mass, more preferably 85 to 95% by mass. Preferred examples of water include ion-exchanged water, distilled water, and RO water.

Additives commonly used in cosmetics, pharmaceuticals, and foods can be added to the lubricant for intubation devices of the present invention as long as they do not impair the effects of the present invention.

EXAMPLES The present invention will be described in more detail below based on examples and comparative examples, but the present invention is not limited to the following examples.

1. Lubricant for Intubation Tool [Example 1 and Comparative Example 1]
<Prescription of Lubricant>
The formulations of Example 1 and Comparative Example 1 are as described in Table 1 below (each numerical value means % by mass).

Moreover, the compounds used in Example 1 and Comparative Example 1 are shown below.
Component (A) Pullulan (product name: pullulan for cosmetics, manufactured by Hayashibara Co., Ltd.)
Component (B) xanthan gum (product name: Celtrol T, manufactured by SDP Gokyo Food & Chemical Co., Ltd.)
Component (C) glycerin (product name: RG-S, manufactured by NOF Corporation)
PG (product name: propylene glycol, manufactured by ADEKA Corporation)
Other ion-exchanged water

<Preparation of lubricant>
According to the formulation shown in Table 1, component (A) and ion-exchanged water were placed in a beaker and stirred at 80°C with a magnetic stirrer until uniform. A dispersion of component (B) with component (C) was added thereto and stirred at 80°C. Then, it was cooled, and samples of Example 1 and Comparative Example 1 were obtained.

[Comparative Example 2]
A lidocaine spray (trade name: “Xylocaine Pump Spray”, manufactured by Aspen Japan Co., Ltd. (does not contain pullulan as an additive)), which is often actually used in clinical practice, was used.

2. Evaluation of Lubricants for Intubation Instruments <Evaluation Method>
The intubation tool lubricants of Example 1 and Comparative Examples 1 and 2 in Table 1 were evaluated. There were five items for evaluation: "coefficient of dynamic friction", "visual field of video scope", "prevention of liquid pooling", "elongation" and "influence on cuff".

(Dynamic friction coefficient measurement)
Initial dynamic friction coefficient measurements were made. The test method was based on the Japanese Industrial Standard "JIS K7125 (plastic-film and sheet friction coefficient test method): 1999". A high-precision tensile tester "AG-Xplus (manufactured by Shimadzu Corporation)" was used to measure the dynamic friction coefficient. This device uses a pulley to convert a vertical pulling force into a horizontal one. By pulling a 200 g weight placed on the pedestal, the frictional force between the pedestal and the weight is measured. At this time, a PVC (polyvinyl chloride) sheet was laid on the pedestal, and a PVC or PTFE (polytetrafluoroethylene) sheet was attached to the bottom surface of the weight. At this time, the area of the sheet to be pasted was set to 40 cm ² so that the area of contact between the weight and the pedestal was constant. A sufficient amount of each sample is applied between the sheet on the pedestal and the sheet attached to the weight, the weight is pulled 100 mm at a speed of 500 mm / min, and between PVC-PVC or PVC-PTFE when each sample is interposed The dynamic friction coefficient μ of was measured.
In the evaluation, when the coefficient of dynamic friction μ when PVC-PTFE was combined was 0.11 or less, it was evaluated as "O", and when it was greater than 0.11, it was evaluated as "X".
On the other hand, when the dynamic friction coefficient μ was 0.21 or less in the combination of PVC-PVC, it was marked as “○”, when it was 0.10 or less as “◎”, and when it was greater than 0.21 as “×”. .

(Method for measuring elongation)
By confirming the coatability of each sample, the elongation of the dosage form was compared.
A release film made of PET (product number: PET125SM1, manufactured by Panac Co., Ltd.) was cut into an appropriate size, and 0.2 ml of each sample was dropped in a line at regular intervals using a syringe. After that, the clearance of the Baker-type film applicator was set to 100 μm, each sample was simultaneously coated at an arbitrary speed, and the length of the coating was measured.
In the evaluation, when the length at the time of coating was 15 cm or longer, it was rated as "◯";

(Confirmation of liquid pooling prevention, confirmation of the field of view of the video scope)
Each sample was filled in a spray container and sprayed several times into the lumen of a double-lumen bronchial tube through which any bronchoscope can be passed to confirm whether the bronchoscope can be smoothly inserted. When each sample is applied to the wall surface of the double-lumen bronchial tube, as the viscosity increases, even if a spray container that normally discharges in mist form is used, the sample will no longer be discharged in mist form, and will start to be discharged in droplets. Furthermore, the size of the droplets becomes large, and the lumen of the double-lumen bronchial tube is occupied by the droplets, resulting in a pool of fluid. In such a state, it was found that the sample adhered to the lens at the tip of the bronchoscope through which the specimen was passed, causing disturbance in the image.
It is considered that the sample needs to have an appropriate fluidity so as not to cause pooling of liquid.
The anti-pulling properties of each sample were compared.
About 20 mL of each sample colored with a pigment was poured into the double-lumen bronchial tube which was erected using an appropriate jig, and the appearance at that time was observed. Relatively fluid samples ran down the double-lumen bronchial tube lumen and remained to adequately coat the inner wall. Those with high viscosity did not easily flow down, and some were blocked in the lumen.
In this way, the ability to prevent liquid pooling was evaluated by examining whether or not the lubricant was blocked in the intubation tool when the lubricant was poured into the intubation tool that was actually set upright, and evaluated according to the following criteria. bottom.
“◎”: Flows smoothly “〇”: It can be blocked once, but it will flow within 30 seconds “×”: It will be blocked and will not flow even if left unattended Lubricant was sprayed into the intubation device, and the appearance of the image when the videoscope was inserted was confirmed and evaluated according to the following criteria.
"◯": The field of view was not obstructed and the image was not disturbed.
"Δ": Slight obstruction of the field of view and disturbance of the image.
"X"... The visual field is obstructed.

(Confirmation of effect on cuff)
A balloon called a cuff is attached to the tracheal tube to prevent leaks between the tracheal wall and the tube and to prevent displacement of the tracheal tube. If a liquid anesthetic containing lidocaine adheres to the cuff, it will be damaged in a short time and cause a pinhole. may occur.
Therefore, the cuff portion of the tracheal tube was immersed in each sample for 8 hours, and it was confirmed whether the sample was cloudy or damaged.
In the case of damage such as pinholes, we actually injected air, opened the balloon, submerged it in a water tank, and checked for air leakage.
The results of the above confirmation were evaluated according to the following criteria.
“〇”…No change “×”…Cuff cloudy

<Evaluation results>
The evaluation results in each of the above tests are as shown in Table 1 below.
As for Example 1, all the evaluation results of the coefficient of dynamic friction, the field of view of the videoscope, the elongation, the prevention of liquid pooling, and the effect on the cuff were good.
On the other hand, in Comparative Example 1, there were evaluation items in which sufficient effects were not obtained.
That is, in Comparative Example 1, since the component (A) of the present invention was not contained, all the effects of the lubricant of the present invention could not be achieved at the same time.

The lubricant of the present invention can be applied to the inside of an intubation tool or an endoscope, etc., and has appropriate fluidity and wettability so that it can be inserted smoothly and does not interfere with the field of view of the endoscope. , for example, in the medical field.

Claims (2)

An intubation tool characterized by containing 0.3 to 2% by mass of the following component (A), 0.1 to 2% by mass of the component (B), and 1 to 30% by mass of the component (C) lubricant.
(A) pullulan (B) water-soluble thickener other than component (A) (C) polyhydric alcohol having 3 to 6 carbon atoms The lubricant for an intubation device according to claim 1, wherein component (B) is xanthan gum or carboxyvinyl polymer.